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Amplia says narmafotinib may work across KRAS mutation status

Amplia Therapeutics said pancreatic cancer trial data suggest narmafotinib may work whether or not tumours carry certain KRAS mutations. The company is advancing the drug in four clinical trials for pancreatic, ovarian and lung cancers.

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What happened

Key facts

  • Amplia Therapeutics said pancreatic cancer trial data suggest narmafotinib’s effectiveness may not depend on whether a tumour carries certain KRAS mutations (per The Sydney Morning Herald).
  • Amplia Therapeutics is advancing narmafotinib in four clinical trials for pancreatic, ovarian and lung cancers (per The Sydney Morning Herald).
  • Amplia Therapeutics chief medical officer Dr Jason Lickliter said the company was moving forward with the trials and building on positive clinical data from the ACCENT trial and preclinical data supporting the PRROSE and Lilly combination studies (per The Sydney Morning Herald).
  • Kalkine reported that Amplia Therapeutics received an A$4.78 million R&D tax rebate for FAK inhibitor trials (per kalkine.com.au).

The brief

Amplia Therapeutics said data from its pancreatic cancer trial suggest narmafotinib may work regardless of whether a tumour carries certain KRAS mutations. The finding points to activity across the mutation status addressed in the company’s report, but Amplia described it as a suggestion from trial data rather than a definitive result.

The Sydney Morning Herald reported that Amplia is advancing narmafotinib in four clinical trials covering pancreatic, ovarian and lung cancers. Chief medical officer Dr Jason Lickliter said the company was continuing those trials while building on clinical data from ACCENT and preclinical data supporting the PRROSE and Lilly combination studies.

The article gives earlier ACCENT results as a 36 per cent response rate and median overall survival of 11.1 months. It also reports a 7.8 per cent complete response rate. These are previously reported trial figures; the article’s account of the latest finding focuses on whether narmafotinib’s effectiveness may depend on KRAS mutation status.

The Sydney Morning Herald also reports that two patients had reached two years in the study, while a third remained on treatment after 19 months. Those treatment durations add follow-up detail to the reported trial results, but the article does not identify the patients or provide further information about their outcomes.

Amplia’s next stated operational step is ethics approval, which the article says was expected imminently. Safety and pharmacokinetic data were anticipated in the first half of 2027. The article does not specify the exact date for approval or further detail about the planned data release.

Separately, Kalkine’s headline reports that Amplia received an A$4.78 million R&D tax rebate for FAK inhibitor trials. The headline does not provide details about the rebate or connect it to the pancreatic trial’s mutation-status finding.

Why it matters

  • For patients in Amplia’s pancreatic cancer trial, the reported possibility that narmafotinib may work across certain KRAS mutation statuses could be relevant to how the company evaluates the drug’s potential use; the finding remains a suggestion from trial data.
  • The ACCENT figures reported by The Sydney Morning Herald include a 36 per cent response rate, median overall survival of 11.1 months and a 7.8 per cent complete response rate.
  • Amplia is pursuing narmafotinib across four trials in pancreatic, ovarian and lung cancers, while the reported treatment durations include two patients at two years and a third still receiving treatment after 19 months.
  • Kalkine reported an A$4.78 million R&D tax rebate for Amplia’s FAK inhibitor trials, a separately reported financial detail.

What to watch next

  • Whether Amplia receives the ethics approval that The Sydney Morning Herald said was expected imminently.
  • Whether Amplia reports the safety and pharmacokinetic data anticipated in the first half of 2027.
  • How Amplia advances narmafotinib across its four clinical trials in pancreatic, ovarian and lung cancers.
  • Whether Amplia provides further detail on the A$4.78 million R&D tax rebate reported in Kalkine’s headline.

How it's being covered

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2 source articles · 2 unique outlets
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Where the outlets are based: Asia 100%
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Timeline

Developments from this story's sources, dated background we compiled and fact-checked, and our earlier coverage. Each row says which.
  1. Amplia Therapeutics began the ACCENT study in 2021, testing narmafotinib with the chemotherapy drugs gemcitabine and nab-paclitaxel in people with advanced pancreatic cancer.
    Background · from our historical context
  2. Amplia Therapeutics began the Phase 2 stage of the ACCENT trial of narmafotinib with chemotherapy in advanced pancreatic cancer.
    Background · compiled and fact-checked by Updat3

How we got here

Amplia Therapeutics began the ACCENT study in 2021, testing narmafotinib with the chemotherapy drugs gemcitabine and nab-paclitaxel in people with advanced pancreatic cancer. The clinical need in pancreatic cancer is shaped in part by KRAS: research has found mutations in the KRAS gene in the great majority of pancreatic ductal adenocarcinomas.

The US National Cancer Institute’s 2019 report on the Cancer Genome Atlas project described the genomic characteristics of this cancer, including the prominence of KRAS alterations. Amplia’s ACCENT study was one part of a wider clinical-development programme.

Original sources

2 articles from 2 outlets · Asia · Show all

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